(News Bulletin 247) – AstraZeneca and MSD (Merck) announce that the United States Food and Drug Administration (FDA) has informed it that it will extend the date of the Prescription Drug User Fee Act (PDUFA) by three months to allow more time for a full review of the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The companies will continue to work with the FDA to facilitate the agency’s completion of the review.
In August 2022, the sNDA was granted priority review and AstraZeneca and MSD (Merck) committed to working with the FDA to bring this treatment option to patients with mCRPC.
As a reminder, in November the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the approval of Lynparza in combination with abiraterone and prednisone or prednisolone in the EU for the treatment adult patients with mCRPC for whom chemotherapy is not clinically indicated.
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